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Ethos Radiotherapy System
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref Ethos Radiotherapy System 4.0Ref Ethos Radiotherapy System 5.0
Identity
- Trade Name
- Ethos Radiotherapy System EUDAMEDFDA UDI
- Generic Name
- Linear accelerator system FDA UDI
- Device Name
- Halcyon, Ethos Radiotherapy System EUDAMED
- Model / Reference
- Ethos Radiotherapy System 4.0 EUDAMEDEthos Radiotherapy System 5.0 EUDAMED4.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857235006099 EUDAMEDFDA UDI00857235006105 EUDAMED
- Basic UDI-DI
- 089947500200108PQ EUDAMED
- 510(k) Number
- K222941 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010101 SINGLE ENERGY LINEAR ACCELERATORS EUDAMED
- GMDN Term
- Linear accelerator system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethos Radiotherapy System by Varian Medical Systems, Inc — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 089947500200108PQ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (3)
- EUDAMED 5f1ecebb-366d-4eea-8198-dd49ab723f9d 61 fields · synced Jul 16, 2026
- FDA UDI 837700ac-a9ad-47b7-801c-200619625d9d 33 fields · synced May 29, 2026
- EUDAMED 1e6409e6-bbe3-4c00-af5f-12821dd1daab 61 fields · synced Jul 16, 2026